Acarbose for Kidney Cancer

Overseen By Arnab Basu, MD,MPH

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Alabama at Birmingham

Must not be taking: Steroids, Immunosuppressants, CYP3A4/5 inducers

Disqualifiers: Immunodeficiency, Autoimmune disease, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 2 years

24 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine the safety and tolerability of acarbose in combination of immunotherapy based standard of care therapy in advanced renal cell carcinoma patients.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but you cannot use certain drugs that strongly affect liver enzymes (CYP3A4/5 inhibitors or inducers) within 7 days before starting the trial. It's best to discuss your current medications with the trial team.

Eligibility Criteria

This trial is for adults with advanced kidney cancer who haven't had systemic therapy in the last 3 weeks. They must have a certain level of physical ability, agree to use contraception, and have specific organ function levels. Excluded are those with treated diabetes, psychiatric issues affecting study cooperation, recent major surgery or other treatments, severe allergies to acarbose or standard care drugs.

Inclusion Criteria

I started bone-strengthening treatment at least 2 weeks ago.

I agree to use birth control from the start of the study drug until 120 days after the last dose.

You have a condition that can be measured by the doctor using a specific assessment tool.

Exclusion Criteria

I have not received a live virus vaccine in the last 30 days.

I am currently being treated for an infection.

My diabetes is managed with medication and my HbA1c is below 8.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a combination of immunotherapy and acarbose for metastatic renal cell carcinoma

2 years

Every 3-6 weeks depending on treatment regimen

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Acarbose

Trial Overview The trial tests the safety and effectiveness of acarbose tablets when added to standard immunotherapy in treating advanced renal cell carcinoma. Participants will receive this combination treatment and be monitored for how well they tolerate it and any signs of improvement.

Participant Groups

Group I: Arm 1 Experimental Treatment 1 Intervention

Ipilimumab (1 mg/kg) IV q3wks + Nivolumab (3mg/kg) IV q3wks + Acarbose (upto 100 mg PO TID) followed by Nivolumab 480 mg IV q4 wks + Acarbose (upto 100 mg PO TID) OR Pembrolizumab 200 mg IV q3 wks or 400 mg IV q6 wks + Lenvatinib (up to 20 mg PO Daily) + Acarbose (upto 100 mg PO TID) \[ Frontline/Refractory pts\] OR Lenvatinib (upto 18 mg PO daily) + Everolimus (upto 5 mg PO Daily) + Acarbose (upto 100 mg PO TID) \[ Refractory pts\] OR Cabozantinib (upto 60 mg PO Daily) + Acarbose (upto 100 mg PO TID) \[Refractory pts\]

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+